Valganciclovir hydrochloride is a potent antiviral agent that has been approved for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) and for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplantation. Valganciclovir hydrochloride is the L-monovaline ester of ganciclovir and is a stable prodrug of ganciclovir with improved absorption. Such characteristics are especially valuable for suppression of herpetic infections in immunocompromised patients where oral administration therapeutically is the preferred choice. Valganciclovir hydrochloride is described in detail in U.S. Pat. No. 6,083,953, which disclosure is incorporated by reference herein.
In the solid state, valganciclovir hydrochloride exhibits acceptable physical, chemical, and light stability when stored under ambient conditions. No special storage requirements are necessary except that excessive humidity must be avoided. Initial attempts to formulate a valganciclovir hydrochloride pediatric preparation and a formulation for patients who require flexibility of dosage focused on the development of an oral liquid product. However, short-term stability data indicated that a liquid dosage form would be unstable for the anticipated shelf life of the product. Accordingly, there is a need for a valganciclovir hydrochloride formulation for pediatric use and for patients who require flexibility of dosage.